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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Adverse Event Study

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Study Status Completed
Application Number P030016 / PAS001
Date Current Protocol Accepted 06/08/2012
Study Name OSB Lead-Adverse Event Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective Registry with patients reporting outcomes
Study Population Description The device is indicated for adults 21-45 years of age:to correct myopia ranging from -3.0 diopters to < - 15.0 diopters with less, than or equal to 2.5 diopters of astigmatism at the spectacle, plane; * to reduce myopia ranging from greater than -15.0 diopters to - 20.0, diopters with less than or equal to 2.5 diopters of astigmatism at tile spectacle plane; and, with an anterior chamber depth (ACD) 3.00 mm or greater, and a stable refractive history within 0.5 diopter for 1 year prior to implantation. The Study includes subjects who are 21-45 years of age with myopia of -3.0 diopters to -20 diopters.
Sample Size 3,000 eyes will be enrolled

2,000 treated eyes needed with 5-year data

Data Collection Corneal edema, cataract, chronic uveitis, glaucoma, retinal detachment, second surgery, and other complications assessed by patient questionnaire
Follow-up Visits and Length of Follow-up 6, 12, 18, 24, 36,48, and 60 months after implantation
Interim or Final Data Summary
Actual Number of Patients Enrolled A total of 2,999 eyes of 1,547 patients were enrolled in the US between April 2006 through October 2013.
Actual Number of Sites Enrolled 1
Patient Follow-up Rate 100% at 6 months, 100% 12 months, 99.9% 18 months, 98.7% 24 months, 97.4% 36 months, 96.5% 48

months, 96.2% at 60 months (2,125 eyes were followed for 5 years).

Final Safety Findings Cumulative Adverse Event rates at 60 months (upper 90%CI)

Corneal problems: 0.0% (0.18%)

Cataract: 2.0% (2.65%)

Treated intraocular inflammation: 0.2% (0.51%)

Treated IOP or glaucoma: 0.2% (0.52%)

Retinal detachment surgery: 0.2% (0.41%)

Remove, replace, or reposition ICL: 1.8% (2.42%) Other ocular conditions/complications

Glare: 0.8%

Halo: 1.5%

Dryness: 1.3%

Secondary surgery (SSI) to address residual astigmatism: 0.7%

Patients and eyes with multiple adverse events

Adverse Events Patients Eyes

2 78 114

3 6 8

4 4 4

Total 88 126

Most common adverse event combination: Cataract/Lens removal in 69 patients (104 eyes).

Cumulative adverse events and comparison with premarket study:

Adverse Event Post-Market Pre-market Study

Corneal problems 0.3%, (5/2999) 0%, (0/526)

Cataract development 5.1%, (154/2999) 8.6%, (45/526)

Treated intraocular inflammation 0.5%, (14/2999) 0.0%, (0/526)

Treated IOP or glaucoma 1.6%, (47/2999) 1.3%, (7/526)

Retinal Detachment Surgery 0.4%, (13/2999) 0.6%, (3/526)

Remove, replace or reposition ICL 4.2%, (126/2999) 4.3%, (23/526)

Glare 2.6%, (66/2527) 9.6%, (34/351)

Halos 5.6%, (142/2527) 11.5%, (40/350)

SSI for residual astigmatism 76/2527 (3.0%) 21/526 (4.0%)

Note: Data at 60 months after surgery for Post-Market, and at =60 months after surgery for Premarket)

Final Effect Findings This study was required for safety endpoints.
Study Strengths & Weaknesses Strengths:

Sponsor have enrolled the required sample size and completed the follow-up ahead of schedule. Follow-up rate was higher than 96.2% at 60 months. Therefore, sample size at the end of the follow-up exceeded the minimum number required for analysis.

Data quality control showed 91.4% “no adverse event” agreement in a random sample of study data. A comparison with the premarket data showed comparable event rates in Corneal problems, treated intraocular inflammation, treated IOP or glaucoma, retinal detachment surgery, remove, replace or reposition ICL and secondary surgery to address residual astigmatism. However, slightly lower adverse event rates for cataract development, glare and halos were found in the post-approval study.


No concomitant comparator group was included. The study was designed to provide descriptive estimates of the rates for the safety endpoints of interest.

Recommendations for Labeling Changes No label update recommended because although some results of the PAS show lower incidence rates than in premarket, the differences can be explained by differences in data collection methods. For example, in the premarket study the investigators reported changes in lens opacity based on slit lamp observation at each visit, while survey questionnaires were used in the post-approval study, which may capture the practice of physicians who are less likely to report clinically insignificant changes.

OSB Lead-Adverse Event Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report 03/30/2007 03/30/2007 On Time
2 year report 05/30/2009 04/30/2009 On Time
3 year report 12/22/2009 04/29/2010 Overdue/Received
4 year report 12/22/2010 03/07/2011 Overdue/Received
report 07/31/2012 07/27/2012 On Time
annual report 07/31/2013 08/01/2013 Overdue/Received
annual report 08/01/2014 08/01/2014 On Time
annual report 07/31/2015 07/31/2015 On Time
yearly report 07/31/2016 07/27/2016 On Time
Final Report 07/31/2017 07/27/2017 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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